NCT06067347 · Massachusetts General Hospital
A Global Study of the PETAL Consortium
(PETAL)
What this study is about
The goal of this observational study is to correlate molecular alterations with outcomes including how long patients live (OS), time without the disease getting worse (PFS), response rates for patients with a new diagnosis, primary refractory or relapse, of mature T-cell and NK-cell neoplasms (TNKL).
View original scientific description
The goal of this observational study is to correlate molecular alterations with outcomes including overall survival (OS), progression-free survival (PFS), response rates for patients with a new diagnosis, primary refractory or relapse, of mature T-cell and NK-cell neoplasms (TNKL). We hypothesize that machine learning can be leveraged to uncover distinct genetic vulnerabilities that underlie treatment response and resistance for patients with TNKL, thus moving towards personalized treatment solutions.
Primary outcome measures
Overall Survival
Time frame: Up to 4 Years
Difference in overall survival (OS) in subjects with primary refractory versus relapsed mature T-cell and NK-cell neoplasms at the completion of 4 years.
Progression-free Survival
Time frame: Up to 4 Years
Difference in progression-free survival (PFS) in subjects with primary refractory versus relapsed mature T-cell and NK-cell neoplasms at the completion of 4 years.
Duration of Response
Time frame: Up to 4 Years
Difference in duration of response in subjects with mature T-cell and NK-cell neoplasms treated with cytotoxic chemotherapy versus prespecified non-chemotherapeutic choice at the completion of 4 years.
Time to progression
Time frame: Up to 4 Years
Difference in time to progression in subjects with mature T-cell and NK-cell neoplasms treated with cytotoxic chemotherapy versus prespecified non-chemotherapeutic choice at the completion of 4 years.
Number of subjects proceeding to stem cell transplantation
Time frame: Up to 4 Years
Difference in number of subjects bridged to stem cell transplantation (allogeneic or autologous) with mature T-cell and NK-cell neoplasms treated with cytotoxic chemotherapy versus prespecified non-chemotherapeutic choice at the completion of 4 years.
Association of tumor specific somatic variants with treatment response
Time frame: Up to 4 Years
Determine whether tumor specific somatic variants identified at the time of diagnosis predicts response to treatment in subjects with mature T-cell and NK-cell neoplasms at the completion of 4 years in at least 50% of the patients.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Untreated, relapsed, or refractory histologically confirmed mature T-cell or NK-cell neoplasm.
- All subtypes of PTCL are eligible except for T-cell large granular lymphocytic leukemia, cutaneous T-cell lymphoma such as but not limited to mycosis fungoides and transformation, Sézary syndrome, and primary cutaneous CD30+ disorders.
Exclusion criteria
- Precursor T/NK neoplasms, T-cell large granular lymphocytic leukemia, cutaneous T-cell lymphoma such as but not limited to mycosis fungoides and transformation, Sézary syndrome, and primary cutaneous CD30+ disorders.
- Adults who are unable to consent, individuals who are not yet adults such as infants, children and teenagers, pregnant women, and prisoners.
Where
- Duarte, California
- Denver, Colorado
- Tampa, Florida
- Boston, Massachusetts
- Rochester, Minnesota
- Hackensack, New Jersey
- Columbus, Ohio
- Philadelphia, Pennsylvania
- Charlottesville, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 9, 2026 · Source of record for eligibility and locations